Q9 Quality Risk Management
The ICH Harmonised Guideline was finalized under Step 4 in November 2005.
This Guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.
These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug (medicinal) products, biological and biotechnological products).
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Date of Step 4: 9 November 2005
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
Q9(R1) EWG Quality Risk Management
This topic was endorsed by the ICH Assembly in November 2019.
The Q9(R1) EWG is focusing on the following harmonisation activities:
Make limited and specific adjustments to specific chapters and annexes of the current ICH Q9 Guideline on Quality Risk Management (QRM);
Develop specific training materials (with examples) to supplement the existing ICH briefing pack on ICH Q9, as well as to explain and facilitate the implementation and application of the proposed revisions.
Further information can be found in the Q9(R1) Concept Paper and Business Plan.
Date of Step 2b: 18 November 2021
Status: Step 3
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations/Trainings (Click the links below for complete guidelines)
Q8/9/10 Q&As (R4) Q8/Q9/Q10 - Implementation
Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the ICH Q8(R2), Q9 and Q10 Guidelines have resulted in the need for some clarification. The Questions and Answers developed by the Quality Implementation Working Group (IWG) are intended to facilitate the implementation of the Q8(R2), Q9 and Q10 Guidelines, by clarifying key issues.
The document with the first set of Q&As was finalized under Step 4 in April 2009. Since then, new sets of questions were added three times, with the most recent version (Q8/Q9/Q10 Q&As (R4)) approved by the Steering Committee in November 2010. The ICH Quality IWG also prepared “Points to Consider” covering topics relevant to the implementation of Q8(R2), Q9 and Q10, which supplement the existing Questions & Answers and workshop training materials already produced by this group.
The document with the first and second set of Points to Consider was finalized in June and November 2011, respectively.
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Date of Step 4: 11 November 2010
Status: Step 5
Questions & Answers (Click the links below for complete guidelines)
Q8/Q9/Q10 Q&As (R4) Questions & Answers
Other Documents (Click the links below for complete guidelines)
Q8/Q9/Q10 Q&As (R4) Points Consider
Endorsed Documents (Click the links below for complete guidelines)
Q8/Q9/Q10 Q&As (R4) Concept Paper
*These Guidelines Belongs to ICH website.
